3 Production Qms Jobs

Roles and Responsibilities Ensure compliance with regulatory requirements, company policies, and procedures related to production quality management systems (QMS). Develop and maintain documentation for change controls, deviation management, and non-conformance reporting. Collaborate with cross-functional teams to resolve issues related to product quality, process validation, and equipment calibration. Desired Candidate Profile Bachelor's degree in Pharmacy (B.Pharma) or Master's degree in Pharmacy (M.Pharma). Minimum 1-4 years of experience in the pharmaceutical industry with expertise in OSD formulation manufacturing. Strong understanding of BMR/BPR regulations and ability to apply them effectively.

This is where you save and sustain lives At Baxter, we are deeply connected by our mission. No matter your role at Baxter, your work makes a positive impact on people around the world. You'll feel a sense of purpose throughout the organization, as we know our work improves outcomes for millions of patients. Baxter's products and therapies are found in almost every hospital worldwide, in clinics and in the home. For over 85 years, we have pioneered significant medical innovations that transform healthcare. Together, we create a place where we are happy, successful and inspire each other. This is where you can do your best work. Join us at the intersection of saving and sustaining lives-where your purpose accelerates our mission. Production QMS Outline: Production Documentation Key Responsibilities: . Handling of Production change control activities and cross functional change impact assessment. . Handling of Production document change request and cross functional DCR impact assessment. . Execution of CA/PA records and perform effectiveness check of implemented actions. . Perform risk assessment for Production QMS elements as per impact assessment. . NCR/SNCR, Market complaint and Laboratory investigation and prepare report. . Production documentation related to QMS elements, SOP, Audit compliance. . Regulatory observation compliance. . Work for Audit readiness. . Execution of other project assigned time to time. Reasonable Accommodations Baxter is committed to working with and providing reasonable accommodations to individuals with disabilities globally. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application or interview process, please click on the here and let us know the nature of your request along with your contact information. Recruitment Fraud Notice Baxter has discovered incidents of employment scams, where fraudulent parties pose as Baxter employees, recruiters, or other agents, and engage with online job seekers in an attempt to steal personal and/or financial information. To learn how you can protect yourself, review our .

"Hiring Event Announcement" We are organizing a Hiring Event in Hyderabad on April 6th, 2025, for our Quality, Production and operation team of Baxter Injectable Manufacturing, Ahmedabad site. Register now for open positions mentioned below. The registration window opens until 4th April 2025. Engineering, Utility (BE/B.Tech or Diploma Electrical): 4 to 8 years experience in Injectable manufacturing plant with Utility maintenance-electrical site plant maintenance activity Engineering, Technical (BE/B.Tech or Diploma Mechanical): 4 to 8 years experience in an Injectable manufacturing plant with plant machine maintenance, preventive maintenance and breakdown maintenance activity Engineering, Instrumentation/Lab maintenance (BE/B.Tech or Diploma Instrumentation): 4 to 8 years experience in Injectable manufacturing plant with Lab maintenance, calibration, validation, Instrumentation, etc,. activity QA Batch Release (M.Pharm/M.Sc/B.Pharm /B.Sc) : 4 to 8 years experience in QA batch release, Batch record review, release document preparation, release-related compliance and cross-functional team coordination for release activity QA QMS (M.Pharm/M.Sc/B.Pharm /B.Sc) : 3 to 8 years experience in QA QMS team with handling of QMS element, CAPA, deviation, investigation, audit compliance, risk assessment, etc., activity QA Doc Cell (M.Pharm/M.Sc/B.Pharm /B.Sc) : 3 to 7 years experience in QA doc control, Batch record review, document-SOP-log book issuance and retrieval, IRA & annual product review report update, etc,. QA Validation (M.Pharm/M.Sc/B.Pharm /B.Sc) : 3 to 7 years experience in QA validation, thermal validation, Plant machine qualification, utility, process validation, cleaning validation, and facility qualification, QMS, etc,. QA IPQA (M.Pharm/M.Sc/B.Pharm /B.Sc) : 3 to 7 years experience in QA IPQA, line clearance, sampling, Batch record review, in-process quality check, QMS, batch release, etc,. QA IPQAshiftingn chargee (M.Pharm/M.Sc/B.Pharm /B.Sc) : 8 to12 years experience in QA IPQA, shift management, manpower management, QMS, line clearance, sampling, Batch record review, in-process quality check, QMS, batch release, etc,. Micro lab QMS (M.Sc/B.Sc – Microbiology/Biotechnology) : 7 to 12 years experience of micro LAB investigation – OOS, OOT, handling Deviation and CAPA, support in Audit response, SOP preparation, Etc., Micro lab reviewer (M.Sc/B.Sc – Microbiology/Biotechnology) : 7 to 12 Experience in analysis and review of Microbial analysis (BET, MLT, Sterility., etc), Validation of Microbiological analysis (Method validation), good knowledge of LIMS or similar software, prefer the experience of writing lab Investigation MFG QMS (Investigation)(M.Pharm/M.Sc/B.Pharm /B.Sc): 6 to 12 Experience in QA QMS team with expertise in handling of investigation, shop floor compliance, QMS elements, CAPA, deviation, investigation, audit compliance, risk assessment, etc., activity MFG Production (M.Pharm/M.Sc/B.Pharm /B.Sc): 3 to 8 Experience in Injectable production, mixing(batch manufacturing), filling, dispensing, sterilization, autoclave, batch record review etc., activity MFG Packing (M.Pharm/M.Sc/B.Pharm /B.Sc): 3 to 8 Experience in Injectable packing activity. automatic visual inspection machine operation, kit preparation, VIT operator training & qualification, batch record review, etc., activity Date & Time : 6th April 2025 || 09 AM to 2 PM IST Venue : Radisson Hyderabad Hitec City, Hyderabad Registration Link copy : https://talentcommunity.baxter.com/flows/india-ptqmwtvye EEO (Equal Employment Opportunity) This is where Baxter International Inc. is an equal opportunity employer. Baxter evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status, or any other legally protected characteristic.